FDA Drug recall D-0898-2022
RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03
- FDA Drug
- Class II
- completed
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03 by Olympia Compounding Pharmacy, citing lack of assurance of sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0898-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-05-09 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Olympia Compounding Pharmacy |
| Distribution | US |
Product
RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Reason
Lack of assurance of sterility.
Identifiers
| code_info | Lots: B24E09-22 BUD: 02/09/2023; B24F09-22 BUD: 02/09/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0898-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.